Drug Landscape ›
ACLIDINIUM ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 5,113
Most-reported reactions
Dyspnoea — 869 reports (17%) Asthma — 724 reports (14.16%) Wheezing — 611 reports (11.95%) Pneumonia — 465 reports (9.09%) Chronic Obstructive Pulmonary Disease — 461 reports (9.02%) Obstructive Airways Disorder — 455 reports (8.9%) Cough — 453 reports (8.86%) Therapeutic Product Effect Incomplete — 377 reports (7.37%) Bronchiectasis — 375 reports (7.33%) Gastrooesophageal Reflux Disease — 323 reports (6.32%)
Source database →
ACLIDINIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ACLIDINIUM approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for ACLIDINIUM in United States?
Marketing authorisation holder not available in our data.